In this role, the successful candidate will collaborate with internal teams, CROs and external vendors to prepare, review and finalize clinical protocol documents; contribute to aspects and stages of the protocol development and execution from study design planning through final reporting of result.
In this role, the selected candidate will oversee commissioning of new laboratory equipment at lab build-out and subsequently identify additional capabilities and/or new technologies to keep lab at optimal productivity.
In this role, the selected candidate will prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc.)
In this role, the selected candidate will be responsible for operating with minimal supervision, designs, oversees implementation, and interprets and summarizes the results of clinical programs designed to lead to new drug applications or to post-marketing study publications.
In this role, the selected candidate will attain thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and NNI SOPs.